Non-Pharmacological Methods in Heel Lance

This randomized controlled study was designed to compare the effects of Warm Foot Bath, ShotBlocker®, and Buzzy®-applied prior to heel lance-on the vital signs of newborns. Heel lance is one of the most frequently performed invasive procedures during the neonatal period, and the pain and stress experienced during the procedure may lead to alterations in vital parameters such as heart rate, respiratory rate, and oxygen saturation. Therefore, identifying non-pharmacological, safe, and feasible pain management methods is essential for enhancing the quality of nursing care. Data will be collected at three time points: before, during, and after the procedure, and changes in heart rate, respiratory rate, and SpO₂ will be recorded. With parental consent, the procedure will be video-recorded before, during, and after heel lance; the recordings will be anonymized and shared with experts for pain assessment. Additionally, the infant's crying duration and time to bleeding cessation will also be evaluated.

NCT Number	NCT07348731
Lead Sponsor	Atlas University
Conditions	Heel Lance Procedures
Enrollment	90 participants
Start Date	2026-02-25
Primary Completion	2026-02-25 (estimated)
Study Completion	2026-06-15 (estimated)
Updated on ClinicalTrials.gov	2026-06-02